Effects of Mindfulness Meditation on Quality of Sleep, Perceived Stress, Serum Cortisol, and C-reactive Protein in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Quality of Sleep
研究概览
简要总结
Objective: This study aimed to examine the effects of mindfulness meditation on the quality of sleep, perceived stress, serum cortisol, and C-reactive protein in end-stage renal disease patients undergoing hemodialysis.
Methods: An experimental study with a repeated measures design was conducted among 56 patients with end-stage renal disease undergoing hemodialysis at Jahra Hospital, Kuwait, between September 2024 and February 2025. The patients were randomly assigned to the experimental (n = 28) and control groups (n = 28). The experimental group participated in 30-minute mindfulness meditation sessions (three sessions a week for eight weeks) held during their hemodialysis sessions; the participants in the control group were instructed to sit with their eyes closed and relax for 30 min three times a week for eight weeks during hemodialysis sessions. The dependent variables of both groups were measured at baseline (T0), middle of intervention (T1), and end of intervention (T2) using the Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), and Biomedical markers (Access Cortisol Assay and CRP reagent).
详细描述
End-stage renal disease (ESRD), or kidney failure, happens when the kidneys almost completely stop working, usually below 10-15% of normal function. It has been documented as a significant factor in rising rates of disability and mortality worldwide, particularly due to the rising rates of diabetes and hypertension. Globally, the population of individuals with ESRD falls from 4.902 to 9.701 million, with most found in low and middle-income nations. In North Africa and the Middle East, ESRD rates exceed 500 per 100,000 population when age-standardized. In Gulf Cooperation Council (GCC) countries, the average rate of end-stage renal disease was 551 per million people, with Oman having the highest prevalence at 1000 per million and Qatar the lowest at 347 per million. In Kuwait, there were 465 cases of dialysis per million people, while the incidence of dialysis was 100 per million populations.
The Global Burden of Disease reports that impaired fasting plasma glucose, hypertension, sodium-rich diet, heart disease, urinary tract blockages, inflammation, and certain genetic disorders are common risk factors for end-stage kidney disease. The last phase of chronic kidney disease necessitates renal replacement therapy, like dialysis or a kidney transplant, to ensure survival. Both forms of dialysis, hemodialysis or peritoneal dialysis, effectively eliminate toxins and excess fluids from the body, but they do not cure kidney disease. Nevertheless, hemodialysis is an extremely important treatment for individuals with ESRD that enhances health by removing toxins from the body, typically done multiple times a week and lasting several hours.
However, the lives of ESRD patients are impacted by hemodialysis treatment, which brings about various physical and psychosocial stressors during their lengthy treatment. In relation to physical indications, hemodialysis patients are constantly in danger of experiencing intradialytic hypotension, muscle cramps, headache, fatigue, nausea, vomiting, itching, acute hemolysis, air embolism, bloodstream infections, and vascular access stenosis. While stress, insomnia, depression, and anxiety are among the psychological indicators in this group. Additionally, most of these individuals have observed elevated amounts of pro-inflammatory markers in the blood, like C-reactive protein. In this situation, continual stress can harm the immune system by activating the hypothalamic-pituitary-adrenal (HPA) system, including hormones like cortisol, which rises 15 minutes after the stress situation and stays high for multiple hours. During chronic stress and frequent exposure to stressors, a long-term elevation in cortisol levels can harm the hippocampus, reduce sensitivity to cortisol, and enhance cortisol binding to the mineralocorticoid receptor. When cortisol binds to the mineralocorticoid receptor, it triggers the release of pro-inflammatory factors like C-reactive protein (CRP) as a pro-inflammatory response and psychological stress. It often leads to changes in body fluid balance, uremia, and frequent nocturnal muscle cramps, all of which disturb sleep. As the hemodialysis treatment often involves three or more sessions per week, each lasting several hours, it is taxing on the patient's body and disrupts natural circadian rhythms, compounding the effects of sleep disorders. Sleep disorders such as insomnia, restless leg syndrome, and obstructive sleep apnea are common among hemodialysis patients, leading to fatigue, cognitive decline, and increased risk for depression and anxiety. Additionally, poor sleep can exacerbate cardiovascular risks, worsen pain perception, and weaken the immune system, all of which are critical concerns for ESRD patients. These issues are particularly problematic because they affect patients' rest, physiological recovery, and mental health. That's why sleep quality is often severely impaired in patients with ESRD, with rates of sleep disturbances much higher than in the general population or among those with other chronic illnesses.
As a result, reports have shown that ESRD patients sometimes employ ineffective or harmful coping strategies when facing multiple stressors, resulting in negative impacts on their overall physical and psychological well-being, increased vulnerability to infections, and higher rates of mortality and morbidity among this population. On the other hand, mind-body techniques are believed to be beneficial for health by promoting a connection between the mind and body, enhancing present-moment awareness and acceptance without judgment. Mindfulness meditation, a widely practiced mind-body technique, involves focusing on the present moment with an attitude of acceptance and nonjudgment. Mindfulness meditation is hypothesized to target multiple cognitive and emotional processes that contribute to stress and poor sleep quality. It has been shown to enable psychological distance and positive reappraisals, helping to stop automatic, uncontrollable appraisals and decreasing stress and cortisol levels. It has also been shown to decrease ruminative thoughts, diminish emotional reactivity, and promote impartial reappraisal of salient experiences, which together may facilitate sleep. In addition, it has been found to improve physiological indices of stress by cultivating stress and amygdala reactivity, resulting in decreased cortisol responses and pro-inflammatory markers such as CRP. Decreased amygdala reactivity associated with activation of the parasympathetic nervous system decreases cortisol levels, which is its high prolonged levels can cause an increase in glucocorticoid receptor resistance to cortisol and increased circulating markers of inflammation, such as CRP.
Smith suggested in his Attentional Cognitive Behavioral (ABC2) Relaxation theory that two 30-minute sessions of mindfulness meditation per week are necessary to induce relaxation, reduce stress, and enhance overall health on the broader community. His mindfulness format has been suggested as a standardized format with five consecutive parts, each lasting 5 minutes, for a total session time of 30 minutes. Research has shown that this mindfulness meditation is as successful as the more extended method in decreasing stress levels. Also, mindfulness meditation has been shown to be a suitable therapy that improves various aspects of well-being in Arabic societies. In general, studies have shown that mindfulness meditation is a proven method to decrease stress and biomedical markers and improve sleep quality in both ESRD and other chronic patients, impacting them physically, emotionally, and mentally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The data were collected by three research assistants with at least 10 years nursing experiences who were not involved in any other parts of the study. Also, the participants were randomly assigned equally to the study groups using a computerized random numbers procedure carried out by a research assistant who was not involved in any other parts of the study. A research assistant who did not participate in the other study phases collected the data, including blood sampling.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ESRD who underwent hemodialysis thrice weekly for a minimum of one year.
- •Were at least 18 years old.
- •Having a urea reduction rate greater than 65% or Kt/V greater than 1.2 in the past month.
- •Possessing Arabic literacy skills.
- •Agreed to participate.
排除标准
- •Patients with cognitive dysfunction or mental retardation.
- •Suffering from rheumatoid arthritis.
- •Using a hearing aid.
- •Regularly consuming psychopharmacological drugs to reduce stress and improve sleep.
- •Participating in other psychological therapies at the time, or had prior formal training in mindfulness methods or a current meditation practice.
研究组 & 干预措施
Patients with ESRD undergoing hemodialysis receiving mindfulness meditation intervention
The participants in this group were received 30-minute mindfulness meditation sessions 3 times a week for 8 weeks (720 minutes).
Patients with ESRD undergoing hemodialysis who received mindfulness meditation intervention: underwent hemodialysis thrice weekly for a minimum of one year, were at least 18 years old, had at least 65% of urea reduction rate or 1.2 of Kt/V in the past month, were capable of Arabic literacy skills, and agreed to participate.
patients with cognitive dysfunction or mental retardation, suffering from rheumatoid arthritis, using a hearing aid, regularly consuming psychopharmacological drugs to reduce stress and improve sleep, participating in other psychological therapies at the time, or had prior formal training in mindfulness methods or a current meditation practice were excluded from the research.
干预措施: Mindfulness Meditation (Behavioral)
Control group
The control group including patients with ESRD undergoing hemodialysis with the inclusion criteria similar to the experimental group. The participants in this group were instructed to sit with their eyes closed and relaxed for 30 minutes 3 times a week for 8 weeks during hemodialysis sessions to control for the nonspecific effects of social interaction and environment. The timings of the control group sessions were similar to those of the experimental group, whereby if a given experimental group intervention lasted for 30 minutes, the control group participants would be asked to sit with their eyes closed and relax for 30 minutes also. However, upon completion of the study, audio recordings of the intervention protocol were provided and explained to participants in the control group.
结局指标
主要结局
Quality of Sleep
时间窗: 8 weeks
An Arabic version of the Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. The PSQI includes seven dimensions of sleep characteristics: subjective sleep quality (1 item), sleep latency (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (9 items), use of sleeping medication (1 item), and daytime dysfunction (2 items). When the PSQI is scored, seven different scores are calculated for each component, ranging from 0 (no problems) to 3 (severe problems) (Buysse DJ, 1989). The PSQI shows internal consistency and a reliability coefficient (Cronbach's alpha) of 0.83 for its seven components (Buysse DJ, 1989). The Arabic PSQI had a Cronbach's alpha coefficient of 0.77, indicating satisfactory reliability (Al Maqbali et al., 2020). The Arabic version provided accurate and dependable outcomes within Arabic cancer communities (Al Maqbali et al., 2020). In our study, Chronbach's α coefficient for the PSQI was 0.77.
Perceived stress
时间窗: 8 weeks
The Arabic version of the Perceived Stress Scale (PSS) was used to measure the degree to which situations in one's life are appraised as stressful (unpredictable, uncontrollable, or overloaded). It consists of 10 elements assessed using a 5-point Likert scale (0=never, 4=very often) that are mostly not specific to any particular subgroup. Scores range from 0 to 40, with higher scores indicating greater perceived stress levels (Cohen, Kamarck, Mermelstein, \& behavior, 1983). The PSS showed internal consistency coefficients varying from 0.84 to 0.36 and a test-retest reliability of 0.85 (Cohen et al., 1983). The Arabic PSS had a Cronbach's alpha coefficient of 0.80 and an intra-correlation coefficient of 0.90 for test-retest reliability, indicating satisfactory reliability levels (Almadi, Cathers, Mansour, \& Chow, 2012). Almadi et al. (2012) confirmed the suitability of PSS for Arabic individuals. In our study, the Chronbach's α coefficient for the PSS was 0.76.
Cortisol
时间窗: 8 weeks
Serum Cortisol: This biomarker was analyzed using the Access Cortisol Assay-33600 protocol.
C-reactive protein
时间窗: 8 weeks
Serum CRP: This biomarker was analyzed using the CRP Reagent-447280 protocol
次要结局
未报告次要终点
研究者
Sami Alshammari
PhD scientist
University of Jordan
